Pressure-Driven Flow Rate Control Valves

ABSTRACT

A storage container having a base storage compartment configured to receive a divider by which the storage compartment is divided into two or more sub-compartments, wherein divider includes a tool configured to provide a secondary utility or function unrelated to dividing the storage compartment.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.17/081,919, filed Oct. 27, 2020, entitled “Pressure-Driven Flow RateControl Valves”, which claims priority to U.S. Provisional ApplicationNo. 62/934,956, filed Nov. 13, 2019, entitled “Pressure-Driven Flow RateControl Valves”, the disclosures of each of which are incorporatedherein in their entirety.

FIELD OF THE INVENTION

This invention generally relates to valves for use in systems configuredto collect or dispense fluids at a desired flow rate. In particular,this invention relates to control valves comprising various componentsconfigured to maintain a desired flow rate, and/or prevent theoccurrence of an undesirable flow rate. Control valves of the presentinvention may be incorporated into a variety of devices for use withfluids that are sensitive to flow rates, such as biological liquidscomprising live cells, shear-sensitive fluids, emulsions, and chemicallyunstable fluids.

BACKGROUND OF THE INVENTION

There are many instances where it is desirable to transfer a fluid thatis sensitive to flow rate. In these instances it is imperative that asafe flow rate for the fluid be maintained while transferring the fluid.Failure to do so may compromise the quality of the fluid. In instanceswhere the fluid is required for medical treatment or diagnostics,failure to maintain a safe flow rate could result in misdiagnosis, losttime and resources, delayed treatment, serious injury, and potentiallydeath.

In the healthcare setting, clinicians frequently draw blood frompatients immediately after a successful catheter insertion. Often theseblood samples are collected using a vacuum container, wherein a vacuumpressure within the vacuum container is configured to draw blood intothe container as soon as the container is connected to an intravenousaccess device. Vacuum containers are not designed for use withintravenous catheters, but are rather designed for use with intravenousneedles wherein the diameter of the fluid pathway of the intravenousneedle is generally greater than that of the intravenous catheter. Insome instances, vacuum containers are incompatible for use withintravenous catheter lines. For example, a vacuum pressure of a vacuumcontainer may draw the blood sample through the intravenous catheter ata flow rate that damages the live blood cells. Alternatively, a vacuumpressure may be insufficient for a particular intravenous catheter,whereby the fill time is unnecessarily prolonged.

In many instances, a clinician opts to extract blood from a patient'sintravenous catheter using a manual syringe. The syringe offers a levelof control over the draw that automated vacuum containers cannot match.While use of a syringe enhances control opportunities over the draw,sample quality may suffer if a clinician introduces a significant vacuumto reduce fill time.

Thus, while systems and methods currently exist for collecting ordispensing fluids at a desired flow rate, challenges still exist. Thepresent invention addresses and overcomes these challenges.

BRIEF SUMMARY OF THE INVENTION

This invention generally relates to valves for use in systems configuredto collect or dispense fluids at a desired flow rate. In particular,this invention relates to control valves comprising various componentsconfigured to maintain a desire flow rate, and/or prevent the occurrenceof an undesirable flow rate. Control valves of the present invention maybe incorporated into a variety of devices for use with fluids that aresensitive to flow rates, such as biological liquids comprising livecells, shear-sensitive fluids, emulsions, and chemically unstablefluids.

In some instances, the present invention provides a valve forcontrolling flow of a fluid at a desired flow rate, wherein said valvecomprises an enclosure comprising an inlet and an outlet; a primaryfluid path; and a septum positioned within an interior of the enclosureand in proximity to the primary fluid path, the septum comprising afirst configuration at a first fluid pressure within the interior, and asecond configuration at a second fluid pressure within the interior. Insome instances, the septum further comprises a fluid pressure thresholdat which the septum switches from the first configuration to the secondconfiguration. In some instances, the first configuration is an openedconfiguration. In some instances, the first fluid pressure is equal to,or less than the fluid pressure threshold. In some instances, the secondconfiguration is a closed configuration. In some instances, the secondfluid pressure is greater than the fluid pressure threshold.

In some aspects of the invention, a fluid pressure threshold is a fluidvacuum pressure threshold, wherein a vacuum pressure is applied to anoutput end of the valve. In some aspects of the invention, a first fluidpressure is a first fluid vacuum pressure, and a second fluid pressureis a second fluid vacuum pressure.

In some instances, a first configuration of a septum is an openconfiguration, and a first fluid vacuum pressure experienced by theseptum is less than or equal to a fluid vacuum pressure threshold of theseptum. In some instances, a second configuration of the septum is aclosed configuration, and a second fluid vacuum pressure experience bythe septum is greater than a fluid vacuum pressure threshold of theseptum.

In some embodiments, a septum of the present invention comprises anaperture. In some instances, when the septum is in a firstconfiguration, the aperture of the septum is opened, and when in thesecond configuration the aperture is closed. In some embodiments, whenthe septum is in the first configuration the aperture of the septum isclosed, and when in the second configuration the aperture is opened. Insome embodiments, an aperture of the septum comprises at least one ofthe primary fluid path and a secondary fluid path of the valve.

In some instances, an aperture of a septum is opened to a first width ina first configuration of the septum, and reduced to a second width in asecond configuration of the septum, wherein the second width reduces afluid flow or a rate of fluid flow through the aperture. In someembodiments, the second width of the aperture entirely prevents a fluidflow through the aperture and/or the valve.

In some aspects of the invention, a primary fluid path of the valve isunobstructed when the septum is in a first configuration, and obstructedwhen the septum is in a second configuration. In some instances, contactbetween the septum and an interior surface of the valve enclosureobstructs the primary fluid path. In some instances, contact betweenopposing surfaces of the septum, including, but not limited to opposingsurfaces of an aperture of the septum, obstructs the primary fluid pathof the valve. In some instances, a secondary fluid path of the valve isunobstructed by the septum when the septum is in a second configuration.In some instances, a secondary fluid path of the valve is unobstructedby the septum when the septum is in a first configuration.

In some embodiments, a septum of the present invention comprises thesecondary fluid path. In some instances, a septum of the presentinvention comprises a primary fluid path and a secondary fluid path. Insome instances, a primary fluid path of the septum comprises a primaryflow rate capacity that is greater than a secondary flow rate capacityof a secondary fluid path.

In some instances, a septum of the present invention is fixedlypositioned within an interior of a valve. In some instances, a septum ofthe present invention is movable positioned within the interior of avalve.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and arenot restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Example embodiments will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1A is a cross-section view of a valve for controlling flow of afluid, wherein the valve is shown in an open configuration in accordancewith a representative embodiment of the present invention;

FIG. 1B is the valve of FIG. 1A, wherein the valve is shown in a closedconfiguration in accordance with a representative embodiment of thepresent invention;

FIG. 2A is a cross-section view of a valve for controlling flow of afluid, wherein the valve is shown in a first configuration in which afirst fluid path and a second fluid path of the valve are open inaccordance with a representative embodiment of the present invention;

FIG. 2B is the valve of FIG. 2A, wherein the valve is shown in a secondconfiguration in which the first fluid path is closed, and the secondfluid path is open in accordance with a representative embodiment of thepresent invention;

FIG. 3A is a cross-section view of a valve for controlling flow of afluid, wherein the valve is shown in a first configuration in which afirst fluid path and a second fluid path of the valve are open inaccordance with a representative embodiment of the present invention;

FIG. 3B is the valve of FIG. 3A, wherein the valve is shown in a secondconfiguration in which the first fluid path is closed, and the secondfluid path is open in accordance with a representative embodiment of thepresent invention;

FIG. 4A is a cross-section view of a valve for controlling flow of afluid, wherein the valve comprises a septum shown in a firstconfiguration in which a fluid path of the valve is open in accordancewith a representative embodiment of the present invention;

FIG. 4B is the valve of FIG. 4A, wherein the septum is shown in a secondconfiguration by which the fluid path of the valve is closed inaccordance with a representative embodiment of the present invention;

FIG. 5A is a cross-section view of a valve for controlling flow of afluid, wherein the valve comprises a septum shown in a firstconfiguration in which a fluid path of the valve is open, and a fluidpath of the septum is closed in accordance with a representativeembodiment of the present invention;

FIG. 5B is the valve of FIG. 5A, wherein the septum is shown in a secondconfiguration by which the fluid path of the valve is closed, and thefluid path of the septum is open in accordance with a representativeembodiment of the present invention;

FIG. 6A is a cross-section view of a valve for controlling flow of afluid, wherein the valve comprises a septum shown in a firstconfiguration in which a fluid path of the valve is open in accordancewith a representative embodiment of the present invention;

FIG. 6B is the valve of FIG. 6A, wherein the septum is shown in a secondconfiguration by which the fluid path of the valve is closed inaccordance with a representative embodiment of the present invention;

FIG. 7A is a cross-section view of a valve for controlling flow of afluid, wherein the valve comprises a septum shown in a firstconfiguration in which a fluid path of the valve is open, and a fluidpath of the septum is open in accordance with a representativeembodiment of the present invention;

FIG. 7B is the valve of FIG. 7A, wherein the septum is shown in a secondconfiguration by which the fluid path of the valve is reduced by thefluid path of the septum in accordance with a representative embodimentof the present invention;

FIG. 8A is a cross-section view of a valve for controlling flow of afluid, wherein the valve comprises a septum shown in a firstconfiguration in which a fluid path of the valve is open in accordancewith a representative embodiment of the present invention;

FIG. 8B is the valve of FIG. 8A, wherein the septum is shown in a secondconfiguration by which the fluid path of the valve is closed inaccordance with a representative embodiment of the present invention;

FIG. 8C is the valve of FIG. 8B, wherein the septum further comprises afluid path that is open in accordance with a representative embodimentof the present invention;

FIG. 8D is the valve of FIG. 8A further comprising means for manuallyadjusting a position of the septum within an interior of the valve,wherein the septum is shown in a position that allows a maximum desireflow rate of a fluid through a fluid path of the valve in accordancewith a representative embodiment of the present invention;

FIG. 8E is the valve of FIG. 8D, wherein the septum is shown in aposition that minimizes a desired flow rate of a fluid through a fluidpath of the valve in accordance with a representative embodiment of thepresent invention;

FIG. 9A is a cross-section view of a valve for controlling flow of afluid, wherein the valve comprises a septum held in a firstconfiguration by a biasing element, wherein a fluid path of the valve isopen in accordance with a representative embodiment of the presentinvention;

FIG. 9B is the valve of FIG. 9A, wherein the septum is shown in a secondconfiguration by which the fluid path of the valve is closed inaccordance with a representative embodiment of the present invention;

FIG. 10A is a cross-section view of a valve for controlling flow of afluid, wherein the valve comprises a septum held in a firstconfiguration by a biasing element, wherein a fluid path of the valve isopen in accordance with a representative embodiment of the presentinvention;

FIG. 10B is the valve of FIG. 10A, wherein the septum is shown in asecond configuration by which the fluid path of the valve is closed, andwherein the septum is shown with a alternative fluid path in accordancewith one or more representative embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The presently preferred embodiments of the present invention will bebest understood by reference to the drawings, wherein like referencenumbers indicate identical or functionally similar elements. It will bereadily understood that the components of the present invention, asgenerally described and illustrated in the figures herein, could bearranged and designed in a wide variety of different configurations.Thus, the following more detailed description, as represented in thefigures, is not intended to limit the scope of the invention as claimed,but is merely representative of presently preferred embodiments of theinvention.

Referring now to FIG. 1, a valve 100 for controlling the flow of a fluidis shown. Valve 100 generally comprises an enclosure having an inlet102, an outlet 104, and an interior 106 interposed therebetween. Valve100 may comprise any structural form, shape, dimension, or size as maybe desired. In some embodiments, valve 100 comprises an in-linecomponent, wherein inlet 102 is coupled to an upstream fluid line, andoutlet 104 is coupled to a downstream fluid line, such that a fluidflows through a primary fluid path 110 of the valve. In someembodiments, valve 100 is incorporated into a fluid handling component,such as an intravenous catheter, a catheter adapter, a vacuum container,luer connector, or the like, wherein the features of the presentinvention are incorporated in such a way that a fluid flows through aprimary fluid path 110 of the valve. In some embodiments, valve 100 isincorporated into a secondary component of a fluid line, such as afilter or a fluid pump.

Valve 100 may comprise any material compatible for use with a desiredfluid. In some embodiments, valve 100 comprises a polymer material. Insome embodiments, valve 100 comprises a metal material. In someembodiments, valve 100 comprises a rigid material. In some embodiments,valve 100 comprises a semi-rigid or semi-flexible material. In someembodiments, valve 100 comprises a flexible material.

Valve 100 further comprise a septum 120 or other compatible element(such as, for example, a piston) disposed within interior 106 and inproximity to the primary fluid path 110. In some embodiments, a positionof septum 120 in interior 106 is fixed. In some embodiments, septum 120is movably positioned within interior 106. For example, in someembodiments septum 120 may slide forward and/or backwards towards inlet102 and outlet 104. In a further example, septum 120 may be pivotallycoupled to interior 106, such that septum 120 may move between verticaland horizontal positions. In some embodiments, septum 120 is free tomove within interior 106, such as due to the force of gravity, and/ordue to a fluid pressure or a vacuum fluid pressure within interior 106.In some embodiments, movement of septum 120 within interior 106 iscontrolled or otherwise limited, such as by a tether or a biasingelement.

Septum 120 may comprise any material compatible for use with a desiredfluid. In some embodiments, septum 120 comprises a polymer material. Insome embodiments, septum 120 comprises a metal material. In someembodiments, septum 120 comprises a rigid material. In some embodiments,septum 120 comprises a semi-rigid or semi-flexible material. In someembodiments, septum 120 comprises a flexible material.

In some embodiments, septum 120 comprises a fluid pressure threshold(f_(T)) at which septum 120 changes from a first configuration to asecond configuration. As used herein, the term “fluid pressurethreshold” refers to fluid pressure limit of septum 120. When a fluidpressure experienced by septum 120 is less than or, in some instances,approximately equal to the fluid pressure threshold of septum 120,septum 120 assumes and/or maintains a first configuration. However, whena fluid pressure experienced by septum 120 is equal to or greater thanthe fluid pressure threshold of septum 120, septum 120 assumes,transforms, or changes to a second configuration. As used herein, and asapplied to the various embodiments of the present invention, the term“fluid pressure” may refer to positive fluid pressure, and/or vacuumfluid pressure. In some embodiments, a “fluid pressure threshold” ofseptum 120 may alternatively describe a flow rate limit of septum 120,wherein when a flow rate experienced by septum 120 is less than a flowrate limit of septum 120, septum 120 assumes and/or maintains a firstconfiguration, and wherein when a flow rate experienced by septum 120 isequal to or greater than a flow rate limit of septum 120, septum 120assumes, transforms, or changes to a second configuration.

The fluid pressure threshold of a septum may be achieved through designof the septum and/or other components of the valve comprising theseptum. For example, fluid dynamics may be used to increase or decreasethe septum's drag while in the primary fluid path, wherein drag mayincrease or decrease the septum's fluid pressure threshold. Similarly,fluid dynamics may be used to increase or decrease flow efficiencies ofthe primary fluid path. Where the valve comprises an intendedorientation, the mass of the septum may be selected to match a desiredflow rate and/or fluid pressure.

With continued reference to FIG. 1A, septum 120 is shown in a firstconfiguration wherein a primary fluid path 110 is open between inlet 120and outlet 140. In some embodiments, valve 100 is oriented parallel tothe Earth's gravitational force, whereby the fluid pressure threshold ofseptum 120 is equal and opposite to the Earth's gravitational force onseptum 120. When septum 120 experiences a first fluid pressure (f₁) thatis approximately equal to the Earth's gravitational force on septum 120,a first configuration of septum 120 is maintained, whereby the primaryfluid path 110 is open (i.e., the inlet 102 and outlet 104 are in fluidcommunication with the primary fluid path 110). As used herein, the term“first fluid pressure” refers to a desired, compatible fluid pressurefor a fluid that is sensitive to flow rates and/or fluid pressures. Whenseptum 120 experiences a second fluid pressure (f₂) that is greater thanthe fluid pressure threshold of septum 120 (i.e., the Earth'sgravitational force on septum 120), the fluid pressure threshold isovercome and septum 120 assumes a second configuration, wherein septum120 occludes and closes the primary fluid path 110, as shown in FIG. 1B.As used herein, the term “second fluid pressure” refers to an undesired,non-compatible fluid pressure for a fluid that is sensitive to flowrates and/or fluid pressures. For this embodiment, the secondconfiguration of septum 120 prevents all fluid flow through valve 100.Upon reduction of the second fluid pressure, septum 120 resumes thefirst configuration, thereby reopening the primary fluid path 110.

Referring now to FIG. 2A, a valve 200 is shown having a septum 220 in afirst configuration, wherein the valve comprises a primary fluid path210, a part of which is defined by a space between an outer surface ofseptum 220 and an inner wall of interior 206, and wherein valve 200comprises a second fluid path 212, a part of which is defined by anaperture 222 of septum 220. In the first configuration, the fluidpressure threshold (f_(T)) of septum 220 is approximately equal to afirst fluid pressure (f₁), such that septum 220 maintains a positionwithin interior 206 that does not occlude or close primary fluid path210. When septum 220 experiences a second fluid pressure (f₂) that isgreater than the fluid pressure threshold of septum 220, the fluidpressure threshold is overcome and septum 220 assumes a secondconfiguration, wherein septum 220 occludes primary fluid path 210, asshown in FIG. 2B. Unlike the embodiment shown in FIGS. 1A and 1B, thesecond configuration of septum 220 does not prevent all fluid flowthrough valve 200. Rather, the open state of the second fluid path 212is maintained in the second configuration of septum 220.

In some instances, a clinician or other individual operating the deviceshown in FIG. 2B will detect a change in flow rate or fill rate whenseptum 220 assumes the second configuration. As such, the clinician mayreduce the second fluid pressure in order to allow septum 220 to resumethe first configuration. In some instances, a clinician may feel or hearthe contact between septum 220 and the inner wall of interior 206 whenseptum 220 assumes the second configuration, which may signal theclinician to reduce the second fluid pressure.

Referring now to FIG. 3A, a valve 300 is shown having a septum 320 in afirst configuration, wherein the valve comprises a primary fluid path310, a part of which is defined by a space between an outer surface ofseptum 320 and an inner wall of interior 306, and wherein valve 300comprises a second fluid path 312, a part of which is defined by anaperture 308 in proximity to outlet 304. In the first configuration, thefluid pressure threshold (f_(T)) of septum 320 is approximately equal toa first fluid pressure (f₁), such that septum 320 maintains a positionwithin interior 306 that does not occlude or close primary fluid path310. When septum 320 experiences a second fluid pressure (f₂) that isgreater than the fluid pressure threshold of septum 320, the fluidpressure threshold is overcome and septum 320 assumes a secondconfiguration, as shown in FIG. 3B. When in the second configuration,septum 320 occludes primary fluid path 310, but does not occlude thesecond fluid path 312. Rather, the open state of the second fluid path312 is maintained in the second configuration of septum 320.

In some embodiments, a primary fluid path of a valve comprises a singleopening or aperture in a septum. In some embodiments, a primary fluidpath comprises a plurality of openings or apertures in a septum. In someembodiments, a primary fluid path comprises an aperture that is open ata fluid pressure that is equal to or less than a first fluid pressure,and that is partially closed or completely closed at a fluid pressurethat is greater than a first fluid pressure.

Referring now to FIG. 4A, a valve 400 is shown having a septum 420 in afirst configuration, wherein the valve comprises a primary fluid path410, a part of which is defined by an aperture 422 of septum 420. In thefirst configuration, the fluid pressure threshold (f_(T)) of septum 420is greater than first fluid pressure (f₁), whereby aperture 422 is in anopened configuration. When aperture 422 is in an opened configuration,primary fluid path 410 is unobstructed. When septum 420 experiences asecond fluid pressure (f₂) that is greater than or equal to the fluidpressure threshold of septum 420, septum 420 assumes a secondconfiguration whereby aperture 422 is in a closed configuration, asshown in FIG. 4B. When in the second configuration, septum 420 occludesprimary fluid path 410 such that all fluid flow through valve 400 isprevented.

In some embodiments, a septum of the present invention is configured toprogressively limit a flow rate through a valve in response toincreasing flow rates and/or increasing fluid pressures. Accordingly, insome embodiments a septum is configured to provide a linear response toincreases in flow rates and/or fluid pressures, whereby across-sectional diameter of an aperture of the septum is reduced orincreased relative to a change in the flow rate and/or fluid pressureexperienced by the septum. In some embodiments, this is accomplished byproviding a septum having a plurality of fluid pressure thresholds. Insome embodiments, this is accomplished by providing a plurality of fluidpathways that are progressively closed or opened as a septum movesthrough a plurality of configurations linked to a plurality of fluidpressure thresholds.

Referring now to FIG. 5A, a valve 500 is shown having a septum 520 in afirst configuration, wherein the valve comprises a primary fluid path510, a part of which is defined by a first aperture 522 of septum 520.Septum 520 further comprises a second aperture 524. In the firstconfiguration, the fluid pressure threshold (f_(T)) of septum 520 isgreater than first fluid pressure (f₁), whereby aperture 522 is in anopened configuration, and second aperture 524 is in a closedconfiguration. When first aperture 522 is in an opened configuration,primary fluid path 510 is unobstructed. When septum 520 experiences asecond fluid pressure (f₂) that is greater than or equal to the fluidpressure threshold of septum 520, septum 520 assumes a secondconfiguration whereby first aperture 522 is in a closed configuration,and second aperture 524 is in an opened configuration, as shown in FIG.5B. When in the second configuration, primary fluid path 510 isoccluded, and a secondary fluid path 512 is formed through secondaperture 524. In some embodiments, a flow rate through second aperture524 is less than a flow rate through first aperture 522. As such, aclinician may detect a reduction in the flow rate and/or fill rate whenseptum 520 switches from the first configuration to the secondconfiguration. In some embodiments, a change in the flow rate of valve500 will indicate to the clinician that a change in the fluid pressureis needed in order to preserve a desired quality of a fluid flowingthrough valve 500.

Referring now to FIG. 6A, a valve 600 is shown having a septum 620 in afirst configuration, wherein the valve comprises a primary fluid path610, a part of which is defined by a space between an outer surface ofseptum 620 and an inner surface of interior 606. In the firstconfiguration, the fluid pressure threshold (f_(T)) of septum 620 isgreater than first fluid pressure (f₁), whereby septum 620 maintains aposition within interior 606 that does not occlude or close primaryfluid path 610. When septum 620 experiences a second fluid pressure (f₂)that is greater than the fluid pressure threshold of septum 620, thefluid pressure threshold is overcome and septum 620 assumes a secondconfiguration, wherein septum 620 occludes primary fluid path 610, asshown in FIG. 6B. In some embodiments, septum 620 is pivotally coupledto an inner surface of interior 606, such that septum 620 pivots fromthe first configuration to the second configuration. When in the secondconfiguration, septum 620 occludes primary fluid path 610 such that allfluid flow through valve 600 is prevented.

Referring now to FIG. 7A, a valve 700 is shown having a septum 720 in afirst configuration, wherein the valve comprises a primary fluid path710, a part of which is defined by a space between an outer surface ofseptum 720 and an inner surface of interior 706. Septum 720 furthercomprises an aperture 722. In some embodiments, primary fluid path 710does not include aperture 722 when septum 720 is in the firstconfiguration. In some embodiments, primary fluid path 710 does includeaperture 722 when septum 720 is in the first configuration. In the firstconfiguration, the fluid pressure threshold (f_(T)) of septum 720 isgreater than the first fluid pressure (f₁), whereby septum 720 maintainsa position within interior 706 that does not occlude or close primaryfluid path 710. When septum 720 experiences a second fluid pressure (f₂)that is greater than the fluid pressure threshold of septum 720, thefluid pressure threshold is overcome and septum 720 assumes a secondconfiguration, wherein septum 720 occludes primary fluid path 710, asshown in FIG. 7B. When in the second configuration, a secondary fluidpath 712 is formed through aperture 722, such that a reduced flow rateis provided through valve 700.

Referring now to FIGS. 8A to 8E, a valve 800 is shown having a conicalor wedge-shaped septum 820, and a conical or wedge-shaped interiorsurface 806 that tapers inwardly from input 802 towards output 804,wherein the valve comprises a primary fluid path 810, a part of which isdefined by a space between an outer surface septum 820 and interiorsurface 806. With reference to FIG. 8A, septum 820 is shown in a firstconfiguration. In the first configuration, the fluid pressure threshold(f_(T)) of septum 820 is greater than a first fluid pressure (f₁), suchthat septum 820 maintains a position within the interior of valve 800that does not occlude or close primary fluid path 810. In someembodiments, septum 820 comprise a structural element 821 thatcontributes to the fluid pressure threshold of septum 820. For example,in some embodiments septum 820 includes a structural element comprisinga recessed surface configured to increase a surface area of the septumin communication with primary fluid path 810. In some embodiments,septum 820 includes a structural element configured to increase the dragof septum 820 within primary fluid path 810.

When septum 820 experiences a second fluid pressure (f₂) that is greaterthan or equal to the fluid pressure threshold of septum 820, the fluidpressure threshold is overcome and septum 820 assumes a secondconfiguration, as shown in FIG. 8B. When in the second configuration,septum 820 forms a fluid tight seal with interior 806, whereby primaryfluid path 810 is occluded such that all fluid flow through valve 800 isprevented. In some embodiments, septum 820 forms an irreversible fluidtight seal with interior 806. In other embodiments, septum 820 forms atemporary fluid tight seal with interior 806, wherein the fluid tightseal is removed when the first fluid pressure is resumed.

In some embodiments, septum 820 further comprises a groove or channel823 formed in, or otherwise provided on an outer surface of septum 820,as shown in FIG. 8C. When septum 820 is in the second configuration,channel 823 forms a secondary fluid path 812 with interior surface 806,such a fluid may continue to flow through valve 800 via secondary fluidpath 812.

Referring now to FIGS. 8D and 8E, some embodiments of the presentinvention further comprise an external control 850 whereby a position ofseptum 820 may be manually selected by a clinician to achieve apreferred flow rate (F_(p1) and F_(p2)) in response to an undesirablefluid pressure (f₂). External control 850 may include any features orstructures whereby a clinician can manipulate and/or set a position ofseptum 820 within the interior of valve 800. In some embodiments,control 850 comprises a button that is operable coupled to septum 820.In some embodiments, a position of control 850 is adjustable between aplurality of set positions. In some embodiments, a position of control850 is infinitely adjustable.

In some embodiments, the position of control 850 adjusts the volume,capacity, and/or dimensions of primary fluid path 810. As such, control850 may increase or decrease flow through primary fluid path 810. Insome embodiments, structural features of septum 820 and interior surface806, in combination with a proximity between these surfaces determines aflow rate through valve 800. For example, as shown in FIG. 8D, thetapered, conical structures of septum 820 and interior surface 806 ofvalve 800 provide a first flow capacity (C₁) when control 850 is in afirst position, wherein the first flow capacity provides a firstpreferred flow rate (F_(p1)). When control 850 is moved to a secondposition, a distance between the opposing surfaces of septum 820 andinterior surface 806 is reduced to provide a second flow capacity (C₂),wherein the second flow capacity provides a second preferred flow rate(F_(p1)). In some embodiments, a clinician selects a position forcontrol 850 that provides a flow rate that prevents undesired damage toa fluid flowing through valve 800.

Some embodiments of the present invention provide a valve comprising abiasing element configured to control the movement of a septum inresponse to fluid pressures within the valve. Biasing element mayinclude any structure, feature or action that contributes to a positionof the septum within the valve. In some instances, biasing elementbiases the septum towards the input end of the valve. In someembodiments, biasing element biases the septum towards the output end ofthe valve. In some embodiments, biasing element biases the septumtowards a location that is between the input and output ends of thevalve. In some embodiments, biasing element biases the septum towards aninterior wall surface of the valve. In some embodiments, biasing elementis a spring. In some embodiments, biasing element is a tether. In someembodiments, biasing member is deformable. In some embodiments, biasingmember is resilient. In some embodiments, biasing member is flexible. Insome embodiments, biasing member is rigid.

Referring now to FIG. 9A, a valve 900 is shown having a septum 920 in afirst configuration, wherein the valve comprises a primary fluid path910, a part of which is defined by a space between septum 920 and aninterior surface 906 of valve 900. Valve 900 further comprises a springbiasing element 930 interposed between septum 920 and interior surface906, wherein biasing element maintains a position of septum 920 withinvalve 900. In the first configuration, the fluid pressure threshold(f_(T)) of septum 920 and biasing element 930 is greater than firstfluid pressure (f₁), whereby biasing element 930 biases septum 920towards input end 902 to maintain a position of septum 920 that does notocclude or close primary fluid path 910. When septum 920 experiences asecond fluid pressure (f₂) that is greater than or equal to the fluidpressure threshold of septum 920 and biasing element 930, the fluidpressure threshold is overcome and septum 920 assumes a secondconfiguration, wherein biasing element 930 collapses and septum 920occludes primary fluid path 910, as shown in FIG. 9B. When in the secondconfiguration, septum 920 is moved by the second fluid pressure towardsoutput 904 whereby septum 920 contacts output 904 and occludes primaryfluid path 910, such that all fluid flow through valve 900 is prevented.In some embodiments, valve 900 may include secondary fluid paths whichprovide limited fluid flow through valve 900 when septum 920 is in thesecond configuration.

Referring now to FIG. 10A, a valve 1000 is shown having a septum 1020 ina first configuration, wherein the valve comprises a primary fluid path1010, a part of which is defined by a space between septum 1020 and aninterior surface 1006 of valve 1000. Valve 1000 further comprises aspring biasing element 1030 interposed between septum 1020 and interiorsurface 1006, wherein biasing element maintains a position of septum1020 within valve 1000. In the first configuration, the fluid pressurethreshold (f_(T)) of septum 1020 and biasing element 1030 is greaterthan first fluid pressure (f₁), whereby biasing element 1030 biasesseptum 920 away from input 1002 and towards output 1004, to a positionthat does not occlude or close primary fluid path 1010. When septum 1020experiences a second fluid pressure (f₂) that is greater than or equalto the fluid pressure threshold of septum 1020 and biasing element 1030,the fluid pressure threshold is overcome and septum 1030 assumes asecond configuration, whereby biasing element stretches an septum 1020occludes primary fluid path 1010, as shown in FIG. 10B. When in thesecond configuration, septum 1020 is moved by the second fluid pressuretowards output 1004 whereby septum 1020 contacts output 1004 andoccludes primary fluid path 1010, such that all fluid flow through valve900 is prevented. In some embodiments, valve 1000 may include asecondary fluid path 1022 which provides limited fluid flow throughvalve 1000 when septum 1020 is in the second configuration.

The present invention may be embodied in other specific forms withoutdeparting from its structures, methods, or other essentialcharacteristics as broadly described herein and claimed hereinafter. Thedescribed embodiments and examples are to be considered in all respectsonly as illustrative, and not restrictive. The scope of the inventionis, therefore, indicated by the appended claims, rather than by theforegoing description. All changes that come within the meaning andrange of equivalency of the claims are to be embraced within theirscope.

All examples and conditional language recited herein are intended forpedagogical objects to aid the reader in understanding the invention andthe concepts contributed by the inventor to furthering the art, and areto be construed as being without limitation to such specifically recitedexamples and conditions. Although implementations of the presentinventions have been described in detail, it should be understood thatthe various changes, substitutions, and alterations could be made heretowithout departing from the spirit and scope of the invention.

What is claimed is:
 1. A valve for controlling flow of a fluid, saidvalve comprising: an enclosure comprising an inlet and an outlet; aprimary fluid path; and a septum positioned within an interior of theenclosure, the septum comprising a first configuration at a first fluidpressure within the interior, and a second configuration at a secondfluid pressure within the interior, wherein the septum comprises anaperture, and wherein the aperture is opened to a first width in thefirst configuration, and is reduced to a second width in the secondconfiguration, and wherein the second width reduces a fluid flow throughthe aperture.
 2. The valve of claim 1, wherein the septum furthercomprises a fluid pressure threshold at which the septum switches fromthe first configuration to the second configuration.
 3. The valve ofclaim 2, wherein the first configuration is an opened configuration, andthe first fluid pressure is equal to, or less than the fluid pressurethreshold, and the second configuration is a closed configuration, andthe second fluid pressure is greater than the fluid pressure threshold.4. The valve of claim 2, wherein the fluid pressure threshold is a fluidvacuum pressure threshold, the first fluid pressure is a first fluidvacuum pressure, and the second fluid pressure is a second fluid vacuumpressure.
 5. The valve of claim 4, wherein the first configuration is anopen configuration, and the first fluid vacuum pressure is less than orequal to the fluid vacuum pressure threshold of the septum, and thesecond configuration is a closed configuration, and the second fluidvacuum pressure is greater than the fluid vacuum pressure threshold. 6.A valve for controlling flow of a fluid, said valve comprising: anenclosure comprising an inlet and an outlet; a primary fluid path; and aseptum positioned within an interior of the enclosure, the septumcomprising a first configuration at a first fluid pressure within theinterior, and a second configuration at a second fluid pressure withinthe interior, wherein the primary fluid path is unobstructed when theseptum is in the first configuration, and obstructed when the septum isin the second configuration, and wherein contact between the septum andan interior surface of the enclosure obstructs the primary fluid path.7. The valve of claim 6, wherein the septum further comprises a fluidpressure threshold at which the septum switches from the firstconfiguration to the second configuration.
 8. The valve of claim 7,wherein the first configuration is an opened configuration, and thefirst fluid pressure is equal to, or less than the fluid pressurethreshold, and the second configuration is a closed configuration, andthe second fluid pressure is greater than the fluid pressure threshold.9. The valve of claim 7, wherein the fluid pressure threshold is a fluidvacuum pressure threshold, the first fluid pressure is a first fluidvacuum pressure, and the second fluid pressure is a second fluid vacuumpressure.
 10. The valve of claim 9, wherein the first configuration isan open configuration, and the first fluid vacuum pressure is less thanor equal to the fluid vacuum pressure threshold of the septum, and thesecond configuration is a closed configuration, and the second fluidvacuum pressure is greater than the fluid vacuum pressure threshold. 11.The valve of claim 6, wherein the septum is movably positioned withinthe interior.
 12. A valve for controlling flow of a fluid, said valvecomprising: an enclosure comprising an inlet and an outlet; a primaryfluid path; a septum positioned within an interior of the enclosure, theseptum comprising a first configuration at a first fluid pressure withinthe interior, and a second configuration at a second fluid pressurewithin the interior; and a secondary fluid path that is unobstructed bythe septum in the second configuration, wherein the septum comprises theprimary fluid path and the secondary fluid path, and wherein the primaryfluid path comprises a primary flow rate capacity that is greater than asecondary flow rate capacity of the secondary fluid path.
 13. The valveof claim 12, wherein the septum further comprises a fluid pressurethreshold at which the septum switches from the first configuration tothe second configuration.
 14. The valve of claim 13, wherein the firstconfiguration is an opened configuration, and the first fluid pressureis equal to, or less than the fluid pressure threshold, and the secondconfiguration is a closed configuration, and the second fluid pressureis greater than the fluid pressure threshold.
 15. The valve of claim 13,wherein the fluid pressure threshold is a fluid vacuum pressurethreshold, the first fluid pressure is a first fluid vacuum pressure,and the second fluid pressure is a second fluid vacuum pressure.
 16. Thevalve of claim 15, wherein the first configuration is an openconfiguration, and the first fluid vacuum pressure is less than or equalto the fluid vacuum pressure threshold of the septum, and the secondconfiguration is a closed configuration, and the second fluid vacuumpressure is greater than the fluid vacuum pressure threshold.